NO During CPB in Neonates to Reduce Risk of AKI

Cincinnati Children's Hospital Medical Center

Status and phase: Enrolling; Phase 3

Conditions: AKI; Surgery; CHD - Congenital Heart Disease

Treatments: Drug: Oxygen; Drug: Nitric Oxide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04216927

MOD00004808

Details and patient eligibility

About

Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.

Enrollment: 40 estimated patients

Sex: All

Ages: 1 to 31 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.

Exclusion criteria

1. Failure to obtain informed consent from parent/guardian
2. Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
3. Emergency surgery,
4. Episode of cardiac arrest within 1 week before surgery,
5. Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
6. Use of inhaled NO (iNO) immediately prior to surgery,
7. Structural renal abnormalities by ultrasound,
8. Preoperative AKI,
9. Use of other investigational drugs,
10. Weight less than <2 kg,
11. Gestational age <36 weeks,
12. Major extracardiac congenital anomalies,
13. Non-English speakers.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Nitric Oxide

Experimental group

Description:

Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care

Treatment:

Drug: Nitric Oxide

Oxygen

Placebo Comparator group

Description:

Standard CPB without NO administered at any point intraoperatively

Treatment:

Drug: Oxygen